TWO BREAST CANCER DRUGS GET NHS APPROVAL

Two breast cancer drugs have been recommended for use by the NHS in England.

In draft guidance, the National Institute for Health and Care Excellence (NICE) has approved palbociclib (Ibrance) and ribociclib (Kisqali) for patients with advanced breast cancer.

The drugs are thought to slow the growth of the disease and delay the need for other treatments.

Cancer Research UK – who funded the Nobel Prize-winning researchers whose work underpinned the drugs’ development – welcomed the announcement. Rose Gray, senior policy advisor at the charity, said:

“These decisions have taken some time, but we’re pleased that the Government and NICE are taking steps to streamline the process so that patients can access life-saving drugs more quickly,” she said.

The approval (link is external) comes after NICE agreed confidential price deals for the drugs. It had previously rejected palbociclib (link is external) because its cost was too high in relation to its clinical effectiveness.

A sample of the drugs

The drugs can now be given to patients with late stage breast cancer that is classified based on certain molecules being present or absent from the surface of the cancer cells. This type of breast cancer is called hormone sensitive or hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative disease.

The approval comes despite uncertainties about how long the drugs extend overall survival.

NICE looked at either drug taken with another kind of treatment called an aromatase inhibitor, for patients who hadn’t been treated for their advanced breast cancer.

It found that both drugs stalled the growth of the cancer for an extra 10 months on average.

NICE concluded that it was likely that this would result in some improvement in overall survival, although this wasn’t certain from available clinical trial results.

There have been calls for NICE to continue to evaluate new drugs based on how effective they are in NHS patients, and for this to contribute to drug pricing decisions.

By slowing down the advance of the cancer, the drugs can delay the need for chemotherapy, giving women the chance to live their regular life for longer. The two drugs work in a similar way and are given once daily.

The drugs are the first of a new type that slows the progression of cancer by switching off two molecules called CDK 4 and 6. Aromatase inhibitors work by blocking the production of the hormone oestrogen, stopping its ability to fuel some breast cancers.

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said the approvals committee heard from patient experts that delaying the progression of their cancer for as long as possible was highly valued.

Longson added that by postponing disease progression the drugs “may reduce the number of people who are exposed to the often unpleasant side effects of chemotherapy, and delay the need for its use in others”.

“We are pleased therefore that the companies have been able to agree reductions to the price.”

Both drugs cost £2,950 for a cycle of treatment. But the terms of the new pricing deal haven’t been disclosed.

Professor Nicholas Turner, who led clinical trials of palbociclib at The Institute of Cancer Research, London and the Royal Marsden, said the drugs have made a huge difference to women’s lives.

“These drugs have allowed women to live a normal life for longer,” he said.

There are around 45,000 new diagnoses of breast cancer each year in England. It is estimated that around 8,000 people in England would be eligible for treatment with either drug each year.

References

National Institute for Health and Clinical Excellence (2017) Ribociclib for breast cancer